Tobacco remains one of the greatest threats to public health worldwide, with devastating consequences for both individuals and society as a whole. The figures speak for themselves, highlighting the undeniable dangers of smoking:

There are over 1.1 billion smokers in the world. Tobacco is responsible for over 8 million deaths every year, according to the World Health Organization (WHO). That’s equivalent to more than 22,000 deaths a day, or around 15 deaths a minute.

• 1 in 10 deaths worldwide: Smoking is the leading cause of preventable death worldwide, accounting for around one in every 10 deaths. These deaths are due to diseases directly linked to smoking, including cancer, heart disease and respiratory ailments.
• Devastating effects on health: Smoking is associated with a considerable risk of developing serious illnesses, such as lung cancer (responsible for 1.7 million deaths a year), heart disease (over 2 million deaths a year), and chronic respiratory diseases.
• Huge economic impact: The economic cost of smoking is colossal. In addition to healthcare expenses, it leads to lost productivity in the workplace and spending on tobacco control. In 2017, the economic costs of tobacco were estimated at over $1,000 billion.
• Environmental damage: Tobacco has a major environmental impact. Growing tobacco requires large quantities of pesticides and water, leading to significant deforestation. What’s more, cigarette butts are one of the most widespread types of waste in the world.

Faced with the alarming consequences of smoking, and in order to support the more than 780 million smokers who want to quit, currently available medications designed to facilitate smoking cessation offer limited support.

These drugs have modest efficacy when administered daily for several weeks at a time.

Sources: EAGLES study for Patch nicotine and Champix®/Chantix®; ORCA-2 and ORCA-3 studies for cytisine

The duration of current treatments, with daily or even multiple doses, combined with undesirable side effects, lead to very low compliance rates:

• 69% of smokers taking varenicline (Champix®/Chantix®) discontinue their treatment, 45% of them because of side-effects*.
• 62% of smokers using nicotine replacement products discontinue their treatment, of which 15% because of side effects. **

These low levels of compliance reduce real-life efficacy compared with that measured in clinical trials.

Sources: * Catz SL 2011 ; ** Yingst 2015

The global market for smoking cessation medications is estimated at $5.6 billion in 2021, with annual growth of 5.6% between 2021 and 2028 (source: Coherent Market Insights). Nicotine substitutes account for 80% of these sales.

Champix®/Chantix® exceeded $1 billion in annual sales despite

• Poor compliance;
• Significant side effects;
• Prescribing without the option of combining with nicotine replacement therapy;
• Mainly marketed in the United States.

NFL-101 is the only innovative, side-effect-free drug in late-stage clinical development.

NFL Biosciences anticipates an annual market of 1.8 billion euros for NFL-101, based on:

• Superior efficacy;
• A natural product with excellent tolerability and no side effects;
• Very high compliance (only 1 to 2 administrations);
• Prescription alone or in combination with nicotine substitutes;
• 50% lower price than Champix®/Chantix®;
• Worldwide marketing.

The transition to over-the-counter (OTC) status will be examined at a later stage.